PainPhase 1NCT01883102
The Effect of Ablation of Epidermal Nerve Fibers Using Capsaicin Cream
A Phase 1 study testing Capsaicin 0.1% in people with Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy." Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Read more about this study
- Who is it for?
- Ages 39 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Capsaicin 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pain syndrome
- must be able to be in study for one week
Who cannot join
- not able to be in study for one week
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Effect of Ablation of Epidermal Nerve Fibers Using 0.1% Capsaicin Cream on Spontaneous Cutaneous Burning Pain, Tactile Hyperalgesia, and Thermal Hyperalgesia: A Controlled, Masked Trial With an N of 1
This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."
Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.
Read the detailed description
On the first day, two areas of the skin of the subject's right abdomen will be marked and identified as sites A and B. Each day for one week the subject will be asked to grade her degree of discomfort or pain from 1 to 10 at sites marked A and B every two hours beginning at 8 a.m. and ending at 10 p.m.
Each day except for Saturday and Sunday touch-pressure sensation will be evaluated using monofilaments and heat pain sensation at sites A and B. Also evaluated will be touch pressure pain at each of these sites.
On Thursday of the first week 3 mm punch biopsies of the skin will be obtained from sites A and B and another 3 mm punch biopsy will be obtained on Thursday of the following week from sites A and B.
Following the first biopsy, the experimental creams will be applied to sites A and B. One of the experimental creams contains 0.1% Capsaisin in a bland cream. The second cream contains no Capsaisin. 0.1% Capsaisin is known to destroy the small fibers, especially pain fibers in the skin. Both the investigators applying the cream and the subject will not know which experimental cream contains the Capsaisin. The creams will be applied on Thursday of the first week but only after all testing and skin biopsies have been done. The creams will be left in place except when testing is being done, and they will not be applied after the second set of skin biopsies has been obtained.
The creams will be applied by the investigators and by the subject, care being taken so that the tube marked A is applied to the site marked A, and the tube marked B is applied to the site marked B. Between application to the two sites, investigators and the subject will use different gloves and applicators, carefully washing their hands with soap and water between and after applications.
The subject will be asked not to shower or to immerse herself in water but to use sponge baths, avoiding the tested areas, so that the cream does not move to other areas.
- Conditions
- Pain
- Being tested
- Capsaicin 0.1%, Placebo
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsaicin 0.1%Drug
Also called Capzacin
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
PlaceboDrug
Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin 0.1% | Experimental | Capsaicin cream 0.1% will be applied to site A or B on the subject's abdomen daily for 7 days. Receives: Drug: Capsaicin 0.1% |
| Placebo/cream without 0.1% capsaicin | Placebo comparator | The placebo cream will be applied to site A or B on the subject's abdomen daily for 7 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burning pain as measured by a numeric rating scale of 1-10
Measured: 1 week
Secondary outcomes (2)
Tactile hyperalgesia as measured with monofilaments A, B, C, (through I), ranging in providing forces -3, -2, -1 (through +5) In grams
This outcome measure consists of touch pressure testing of tactile hyperalgesia (increased sensitivity to pain) with monofilaments consists of recognizing the lowest level at which the subject can feel the touch of a monofilament hair, and to the point of discomfort or pain.
The units for tactile hyperalgesia are In grams of touch pressure.
Measured: 1 week
Thermal hyperalgesia as measured by the heat as pain thermode test using CASE IVc
This outcome measure tests heat-pain sensation (the lowest degree of a thermal warming pulse that the subject can perceive as discomfort or pain).
CASE IVc is a computerized quantitative sensation testing instrument, extensively described. It was originally developed at Mayo Clinic and the Section of Engineering. It is now manufactured by WR Medical Electronics in Maplewood, Minnesota. This instrument provides exponentially increasing pyramidal and trapezoid heat pulses to a maximum of 49 degrees centigrade for 10 seconds.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter J. Dyck, M.D., Mayo Clinic
- Investigators
- Peter Dyck, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883102
- Sponsor's protocol ID
- 13-002235
- Status last verified
- Jun 2013
- First submitted
- 6 Jun 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ablation of Epidermal Nerve Fibers Using 0.1% Capsaicin Cream on Spontaneous Cutaneous Burning Pain, Tactile Hyperalgesia, and Thermal Hyperalgesia: A Controlled, Masked Trial With an N of 1
- ClinicalTrials.gov ID
- NCT01883102
- Acronym / sponsor ID
- 13-002235
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of epidermal (the outer most layer) nerve fibers (ENFs) in the skin of the body; counts of which are used to determine a disease of nerves called "small nerve fiber neuropathy."
Capsaicin is approved by the Food and Drug Administration (FDA) for pain relief. Since 0.1% capsaicin is known to cause ablation (removal) of ENFs, this study will test whether such ablation results in relief of spontaneous pain, touch, or heat-pain.
Detailed description
On the first day, two areas of the skin of the subject's right abdomen will be marked and identified as sites A and B. Each day for one week the subject will be asked to grade her degree of discomfort or pain from 1 to 10 at sites marked A and B every two hours beginning at 8 a.m. and ending at 10 p.m.
Each day except for Saturday and Sunday touch-pressure sensation will be evaluated using monofilaments and heat pain sensation at sites A and B. Also evaluated will be touch pressure pain at each of these sites.
On Thursday of the first week 3 mm punch biopsies of the skin will be obtained from sites A and B and another 3 mm punch biopsy will be obtained on Thursday of the following week from sites A and B.
Following the first biopsy, the experimental creams will be applied to sites A and B. One of the experimental creams contains 0.1% Capsaisin in a bland cream. The second cream contains no Capsaisin. 0.1% Capsaisin is known to destroy the small fibers, especially pain fibers in the skin. Both the investigators applying the cream and the subject will not know which experimental cream contains the Capsaisin. The creams will be applied on Thursday of the first week but only after all testing and skin biopsies have been done. The creams will be left in place except when testing is being done, and they will not be applied after the second set of skin biopsies has been obtained.
The creams will be applied by the investigators and by the subject, care being taken so that the tube marked A is applied to the site marked A, and the tube marked B is applied to the site marked B. Between application to the two sites, investigators and the subject will use different gloves and applicators, carefully washing their hands with soap and water between and after applications.
The subject will be asked not to shower or to immerse herself in water but to use sponge baths, avoiding the tested areas, so that the cream does not move to other areas.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin 0.1% | Experimental | Drug: Capsaicin 0.1%Capsaicin cream 0.1% will be applied to site A or B on the subject's abdomen daily for 7 days. |
| Placebo/cream without 0.1% capsaicin | Placebo comparator | Drug: PlaceboThe placebo cream will be applied to site A or B on the subject's abdomen daily for 7 days. |
Who may qualify
- Ages
- 39 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- pain syndrome
- must be able to be in study for one week
Key exclusion criteria (1 listed)
- not able to be in study for one week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capsaicin 0.1%Also: CapzacinCream will be cleansed from sites A and B with soap and water each morning before reapplying. | Drug | Capsaicin 0.1% |
| PlaceboCream will be cleansed from sites A and B with soap and water each morning before reapplying. | Drug | Placebo/cream without 0.1% capsaicin |
Primary outcome
Burning pain as measured by a numeric rating scale of 1-10
Time frame: 1 week
2 secondary outcomes
Tactile hyperalgesia as measured with monofilaments A, B, C, (through I), ranging in providing forces -3, -2, -1 (through +5) In grams
Time frame: 1 week
Thermal hyperalgesia as measured by the heat as pain thermode test using CASE IVc
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Dyck, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Capsaicin 0.1% in people with Pain, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burning pain as measured by a numeric rating scale of 1-10 (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2013.